Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250 Milligrams, 500 Milligrams, 1 Gram, 2 Grams, and 10 Grams Base/Vial, Approved Under New Drug Application 050585, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 14023-14024 [2011-5947]
Download as PDF
<![CDATA[
14023
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
806.10 .................................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
CFR section
666
Total annual
responses
1
666
Average
burden per
response
(in hours)
Total
hours
10
6660
Average
burden per
recordkeeping
(in hours)
Total
hours
10
900
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
CFR section
806.20 .................................................................................................
1 There
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–P–0177]
Determination that ROCEPHIN
(Ceftriaxone Sodium) Injection, 250
Milligrams, 500 Milligrams, 1 Gram, 2
Grams, and 10 Grams Base/Vial,
Approved Under New Drug Application
050585, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) has determined
ROCEPHIN (ceftriaxone sodium)
Injection, 250 milligrams (mg), 500mg, 1
gram (g), 2g, and 10g base/vial,
approved under new drug application
(NDA) 050585, were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for any of
these products if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:50 Mar 14, 2011
Jkt 223001
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of an NDA.
The only clinical data required in an
ANDA are data to show that the drug
that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
SUPPLEMENTARY INFORMATION:
[FR Doc. 2011–5916 Filed 3–14–11; 8:45 am]
ACTION:
90
Total annual
records
1
90
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Number of
records per
recordkeeper
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
ANDA that does not refer to a listed
drug.
ROCEPHIN (ceftriaxone sodium)
Injection, 250mg, 500mg, 1g, 2g, and 10g
base/vial, are the subject of NDA 050585
held by F. Hoffman-La Roche Ltd. (La
Roche). ROCEPHIN (ceftriaxone
sodium) is a semisynthetic
cephalosporin antibiotic for intravenous
or intramuscular administration and is
indicated for the treatment of certain
infections as described in the labeling.
The drug products approved under NDA
050585 are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Steven H. Sklar of Leydig, Voit &
Mayer, Ltd., submitted a citizen petition
dated April 3, 2009 (Docket No. FDA–
2009–P–0177), under 21 CFR 10.30,
requesting that FDA determine that
ROCEPHIN (ceftriaxone sodium)
Injection, 250mg, 500mg, 1g, 2g, and 10g
base/vial, approved under NDA 050585,
were withdrawn from sale for reasons
other than safety or effectiveness.
After considering the citizen petition
and reviewing Agency records, FDA has
determined under § 314.161 that
ROCEPHIN (ceftriaxone sodium)
Injection, 250mg, 500mg, 1g, 2g, and 10g
base/vial, approved under NDA 050585,
were not withdrawn from sale for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that these
products were withdrawn from sale for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
these products from sale. We have also
independently evaluated the relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that any of these products were
E:\FR\FM\15MRN1.SGM
15MRN1
14024
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ROCEPHIN (ceftriaxone
sodium) Injection, 250mg, 500mg, 1g,
2g, and 10g base/vial, approved under
NDA 050585, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
withdrawn from sale for reasons other
than safety or effectiveness. ANDAs that
refer to any of the products described in
this notice may be approved by FDA as
long as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for any of these drug products
should be revised to meet current
standards, the Agency will advise
ANDA applicants to submit such
labeling.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5947 Filed 3–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0104]
Draft Guidance for Industry on NonPenicillin Beta-Lactam Risk
Assessment: A CGMP Framework;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Non-Penicillin BetaLactam Risk Assessment: A CGMP
Framework.’’ This guidance describes
the importance of implementing
appropriate steps during the
manufacturing process to prevent crosscontamination of finished
pharmaceuticals and active
pharmaceutical ingredients (APIs) with
non-penicillin beta-lactam antibiotics.
The draft guidance is intended to assist
manufacturers in assessing whether
separate facilities should be used based
on the relative health risk of crossreactivity.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:50 Mar 14, 2011
Jkt 223001
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 16, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research (CDER),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm.
2201, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request. The guidance may also be
obtained by mail by calling CDER at
301–796–3400. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments
concerning the draft guidance to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Edwin Melendez, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4370,
Silver Spring, MD 20993–0002, 301–
796–3284.
SUPPLEMENTARY INFORMATION:
following types of cross-contamination:
(1) Non-penicillin beta-lactam
contamination in a non-beta-lactam
product (e.g., cefaclor in aspirin) and (2)
non-penicillin beta-lactam
contamination in another non-penicillin
beta-lactam (e.g., cephalexin in
imipenem).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on non-penicillin beta-lactam risk
assessment. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Non-Penicillin Beta-Lactam Risk
Assessment: A CGMP Framework.’’ This
draft guidance describes the importance
of implementing appropriate steps
during the manufacturing process to
prevent cross-contamination of finished
pharmaceuticals and APIs with nonpenicillin beta-lactam antibiotics. It also
provides information regarding the
relative health risk of, and the potential
for, cross-reactivity in the classes of
sensitizing beta-lactams (penicillins and
non-penicillin beta-lactams).
Drug cross-contamination is the
contamination of one drug with one or
more different drugs. Crosscontamination with non-penicillin betalactam drugs can initiate drug-induced
hypersensitivity reactions, including
anaphylaxis, an allergic reaction that
may be a life-threatening event. One
critical aspect of manufacturing nonpenicillin beta-lactam drugs is
preventing cross-contamination to
reduce the potential for drug-induced,
life-threatening allergic reactions. FDA
is recommending that manufacturers
establish appropriate separation and
control systems designed to prevent the
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5948 Filed 3–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0150]
Guidance for Industry on Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14023-14024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5947]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-P-0177]
Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250
Milligrams, 500 Milligrams, 1 Gram, 2 Grams, and 10 Grams Base/Vial,
Approved Under New Drug Application 050585, Were Not Withdrawn From
Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined ROCEPHIN
(ceftriaxone sodium) Injection, 250 milligrams (mg), 500mg, 1 gram (g),
2g, and 10g base/vial, approved under new drug application (NDA)
050585, were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for any of these products if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of an NDA. The only clinical data required in an ANDA
are data to show that the drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162). Under Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)), the
Agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
ROCEPHIN (ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and
10g base/vial, are the subject of NDA 050585 held by F. Hoffman-La
Roche Ltd. (La Roche). ROCEPHIN (ceftriaxone sodium) is a semisynthetic
cephalosporin antibiotic for intravenous or intramuscular
administration and is indicated for the treatment of certain infections
as described in the labeling. The drug products approved under NDA
050585 are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Steven H. Sklar of Leydig, Voit & Mayer, Ltd., submitted a citizen
petition dated April 3, 2009 (Docket No. FDA-2009-P-0177), under 21 CFR
10.30, requesting that FDA determine that ROCEPHIN (ceftriaxone sodium)
Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved under NDA
050585, were withdrawn from sale for reasons other than safety or
effectiveness.
After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec. 314.161 that ROCEPHIN
(ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/
vial, approved under NDA 050585, were not withdrawn from sale for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that these products were withdrawn
from sale for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of these
products from sale. We have also independently evaluated the relevant
literature and data for possible postmarketing adverse events. We have
found no information that would indicate that any of these products
were
[[Page 14024]]
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list ROCEPHIN (ceftriaxone
sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved
under NDA 050585, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been withdrawn from sale for
reasons other than safety or effectiveness. ANDAs that refer to any of
the products described in this notice may be approved by FDA as long as
they meet all other legal and regulatory requirements for the approval
of ANDAs. If FDA determines that labeling for any of these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5947 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P
